- 2 - 
As a result of these changes the institutions through Institutional Biosafety Coro- 
mittees (IBCs) will have principal responsibility and authority for determining and 
monitoring compliance. This means the University and NIH must be clear about 
their separate and joint responsibilities and must respond expeditiously to the 
standards that have been established. On this latter point I want to suggest 
a change in the proposed revised guidelines brought to my attention by an IBC 
member. Section V 3 of Appendix C (p. 33094) should include guidance to an 
IBC through inclusion of some examples of criteria that have been used in the 
past in granting single step reductions in physical or biological containment 
levels. This will assist IBCs to achieve consistency in their interpretation 
and approval practices. 
The proposed revised guidelines at the same time seem better able to protect 
i 
health and safety and the environment. Their applicability has been expanded 
to include all recombinant DNA research at an institution receiving NIH funding 
irrespective of the source of funding for the research, and they now provide for 
private industry participation on a voluntary basis. Membership on an IBC now 
must include at least one public member and for institutions with investigators 
engaged in relatively high risk experiments, a biological safety officer. In 
addition, sanctions are now available to NIH to suspend, limit or terminate 
grants in response to non-compliance which may be useful. 
[A-442] 
